NCT00373685已完成4 期
Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 8,067 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,067
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
研究概览
简要总结
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.
排除标准
- •GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
- •Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
研究组 & 干预措施
Celecoxib
Experimental
dosing as per USPI label
干预措施: Celecoxib (Drug)
NSAIDs
Active Comparator
干预措施: Any commercially available NSAID with the indication for osteoarthritis (Drug)
结局指标
主要结局
Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
时间窗: Baseline through week 24 or Early Termination (ET)
CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.
次要结局
- Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)(Baseline through week 24 or ET)
- Hemoglobin (Hb) at Baseline(Baseline)
- Hematocrit (Hct) at Baseline(Baseline)
- Percentage of Participants With Moderate to Severe Abdominal Symptoms(Baseline through week 24 or ET)
- Change From Baseline Hb at Week 24(Baseline and Week 24 or ET)
- Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief(Baseline, Weeks 8, 16, 24 or ET)
- Change From Baseline Hct at Week 24(Baseline and Week 24 or ET)
- Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline(Baseline, Weeks 8, 16, 24 or ET)
- Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief(Baseline, Weeks 8, 16, 24 or ET)
- Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall(Baseline, Weeks 8, 16, 24 or ET)
- Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief(Baseline, Weeks 8, 16, 24 or ET)
研究者
研究点 (1)
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